Angiography with PCI no better than medical therapy in stable CAD with CKD: ISCHEMIA- CKD trial

USA: Initial invasive strategy in patients with stable ischemic heart disease (SIHD) and chronic kidney disease (CKD) did not reduce adverse clinical outcomes (death and myocardial infarction) compared to an initial conservative OMT (optimal medical therapy) strategy, suggests findings from ISCHEMIA-CKD trial.

Findings of the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches- Chronic Kidney Disease (ISCHEMIA-CKD) was presented at the American Heart Association Scientific Sessions 2019.

Cardiovascular disease is the leading cause of death among patients with advanced chronic kidney disease (CKD). Yet, CKD patients are not being studied adequately in contemporary trials of revascularization versus medical management for SIHD. Patients with cardiovascular disease and advanced CKD are also medically undertreated owing to increasing concern for medical-related adverse events. Also, advanced CKD patients are at increased risk for short-term complications including dialysis, major bleeding, acute kidney injury and short-term risk of death.

Sripal Bangalore, New York University School of Medicine, New York, NY, and colleagues evaluate clinical outcomes in the comparison of an initial invasive approach to conservative, OMT in CKD patients with SIHD and moderate or severe ischemia.

The trial was conducted across 30 countries involving 777 patients with advanced CKD (estimated glomerular filtration rate less than 30 mL/min/1.73 m² or on dialysis), stable ischemic heart disease, and at least moderate ischemic on an exercise or pharmacologic stress test. The median age was 63, and 31% of patients were women. Slightly more than half (53%) were on dialysis. Of the remaining patients, 86% had stage 4 and 14% had stage 5 CKD.

They were randomized in the ratio 1:1 to a routine invasive approach—coronary angiography followed revascularization in appropriate patients—plus optimal medical therapy or to optimal medical therapy alone (patients in this arm were treated invasively if their symptoms worsened or there was an emergent reason). Ultimately, coronary angiography was performed in 85% of patients in the invasive arm and 22% of those in the conservative arm, with revascularization performed in 50% and 12%, respectively. Revascularization was primarily done with PCI (85%), with CABG used in the rest.

Key findings of the study include:

• Primary Endpoints Results:
  
  
  
  • Composite of death or nonfatal myocardial infarction (MI)
    
    
    
    • Initial invasive strategy 36.4%; conservative strategy 36.7% (HRadj 1.01).
    
    
    
    
  
  
  
  Secondary Endpoints Results:
  
  
  
  • Death, non-fatal MI, Hospitalization for Unstable Angina or Heart Failure or Resuscitated Cardiac Arrest
    
    
    
    • Initial invasive strategy 38.5%; conservative strategy 39.7% (HRadj 1.02)
    
    
    
    
  
  
  • Death
    
    
    
    • Initial invasive strategy 27.2%; conservative strategy 27.8% (HRadj 1.03)
    
    
    
    
  
  
  • Cardiovascular Death (invasive vs conservative strategy): HRadj 0.97
  
  
  • Myocardial infarction (invasive vs conservative strategy): HRadj 0.84
  
  
  • Procedural MI (invasive vs conservative strategy): HRadj 2.03
  
  
  • Spontaneous MI (invasive vs conservative strategy): HRadj 0.72
  
  
  • Unstable angina (invasive vs conservative strategy): HRadj 0.15
  
  
  • Heart Failure (invasive vs conservative strategy): HRadj 1.47
  
  
  • Stroke (invasive vs conservative strategy): HRadj 3.76
  
  
  
  

"These results do not apply to patients with current/recent acute coronary syndrome, highly symptomatic patients, or left ventricular ejection fraction <35%. Overall, mortality was high and not impacted (positively or negatively) by routine invasive therapy," concluded the authors.

The International Study of Comparative Health Effectiveness With Medical and Invasive Approaches—Chronic Kidney Disease Trial was presented at the 2019 AHA Meeting.